MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER PICCOLO; OCCLUDER, PATENT DUCTUS, ARTERIOSUS

Model Number	OCCLUDER
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Obstruction/Occlusion (2422)
Date of Event	03/29/2023
Type of Reportable Event	Death
Event or Problem Description
It was reported that on (b)(6) 2023, a 4mm by 2mm amplatzer piccolo occluder was chosen for procedure using a 4f amplatzer torqvue low profile catheter.The patient was a 22 day old, 650 g patient with the following patent ductus arteriosus (pda) dimensions measured by angiogram and transthoracic echocardiogram (tte): minimal diameter of 2.6mm, diameter at aortic ampulla of 3.5mm, length of 7mm.The 4mm by 2mm occluder was deployed but but appeared slightly large for the defect, so it was removed prior to release from delivery cable.A 3mm by 2mm amplatzer piccolo occluder was selected for implant, and the device was placed into the patent ductus arteriosus (pda), and it was implanted intraductal.The device apeared to be in a stable position, but shortly thereafter, the device completely dislodged and embolized into the patient's right pulmonary artery, causing a partial obstruction.The device was attempted to be retrieved via transcatheter snare.During retrieval of the device, the patient had a prominent subcutaneous chest wall hemorrhage, which was related to the patient's past medical history of bleeding diathesis.Blood transfusions were administered, and chest compressions were performed.The patient became hemodynamically unstable and expired on (b)(6) 2023.The device was unable to be retrieved.The cause of the embolization was reported to be due to dynamic ductus anatomy, and the death was related to the bleeding.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that on (b)(6) 2023, a 4mm by 2mm amplatzer piccolo occluder was chosen for procedure using a 4f amplatzer torqvue low profile catheter.The patient was a 22 day old, 650 g patient with the following patent ductus arteriosus (pda) dimensions measured by angiogram and transthoracic echocardiogram (tte): minimal diameter of 2.6mm, diameter at aortic ampulla of 3.5mm, length of 7mm.The 4mm by 2mm occluder was deployed but appeared slightly large for the defect, so it was removed prior to release from delivery cable.A 3mm by 2mm amplatzer piccolo occluder was selected for implant, and the device was placed into the patent ductus arteriosus (pda), and it was implanted intraductal.The device appeared to be in a stable position, but shortly thereafter, the device completely dislodged and embolized into the patient's right pulmonary artery, causing a partial obstruction.The device was attempted to be retrieved via transcatheter snare.During retrieval of the device, the patient had a prominent subcutaneous chest wall hemorrhage, which was related to the patient's past medical history of bleeding diathesis.Blood transfusions were administered, and chest compressions were performed.The patient became hemodynamically unstable and expired on (b)(6) 2023.The device was unable to be retrieved.The cause of the embolization was reported to be due to dynamic ductus anatomy, and the death was related to the bleeding.
Additional Manufacturer Narrative
An event of dislodged and embolized into the patient's right pulmonary artery causing a partial obstruction and patient death was reported.It was also reported that during retrieval of the device, the patient had a prominent subcutaneous chest wall hemorrhage, which was related to the patient's past medical history of bleeding diathesis.A review of the ductal measurements as reported from the field was performed.A returned device assessment could not be performed as the device and was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Based on the information received, the cause of the reported incident could potentially be related to the use of smaller than the recommended device size.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.Please note that per the sizing table in the instructions for use, arten600042307 - c, sizing chart t3, the recommended size devices for patient is 4-2 mm amplatzer piccolo occluder.

• Brand Name: AMPLATZER PICCOLO
• Common Device Name: OCCLUDER, PATENT DUCTUS, ARTERIOSUS
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL REG# 2135147; 5050 nathan ln n; plymouth MN 55442
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 16744378
• Report Number: 2135147-2023-01660
• Device Sequence Number: 5378033
• Product Code: MAE
• UDI-Device Identifier: 05415067030979
• UDI-Public: 05415067030979
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: P020024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: OCCLUDER
• Device Catalogue Number: 9-PDAP-03-02-L
• Device Lot Number: 8713192
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/29/2023
• Supplement Date Received by Manufacturer: 06/08/2023
• Initial Report FDA Received Date: 04/14/2023
• Supplement Report FDA Received Date: 06/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/17/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AMPLATZER TORQVUE LP CATHETER, 9-TVLPC4F90/080
• Outcome Attributed to Adverse Event: Death
• Patient Age: 22 DA
• Patient Sex: Female
• Patient Weight: 1 KG